Biopharma start-ups need to identify the best data-management processes and systems – but to do so means they need to avoid the mistakes made by Big Pharma. Frits Stulp and Duncan van Rijsbergen of Iperion – a Deloitte company – outline a blueprint for best practice.
The biopharma industry is burgeoning, and for ambitious upcoming biotechs, starting out as they mean to go on – with reliable 360-degree product and process visibility – will set them in good stead for the future. But what does this mean in practice?
Young companies often look to more-established players for how to keep records and master regulatory rigor, but in life sciences the big players are not the best model to follow. These companies often brought in technology systems on a targeted, need-oriented basis, restricted by what was available at the time and what would work with their legacy IT systems.
For new organizations with the luxury of a clean slate, it makes sense to capitalize on emerging best practice: being data-driven from day one.
Begin at the beginning
The first challenge for biotechs is that excelling scientifically has usually been their primary focus up to now. Any investment they have secured will be channeled into the compounds they’re working on and bringing them to market. At this stage, they may not appreciate the need to capture information in a structured way or to invest in formal infrastructure.
But even at the start, biotech teams generate and compile information, in the form of lab reports or other records. If this activity is unstructured (informal manual notes, spreadsheet-based readings, Word documents), it will only store up problems for later. When, eventually, they’re ready to go to market, they’ll need to find and collate all that information to smooth the path to authorization. And this is where they may encounter pain points due to poor information management.
Adopt a data-based mindset
It is much better to embrace information or data-management considerations and appropriate technology right from the outset – which starts with appointing a chief technology officer or information/data ‘evangelist’ and bringing them to the table for even the earliest scientific discussions.
This way, the biotech adopts a data-based mindset and discipline from day one, understands the value and role of all the information it captures, and maintains this in a way that will help bring products swiftly to market.
Standardized, accessible records
The objective should be to record everything in a standardized, accessible and combinable way, to set the company in good stead for the 360-degree transparency that all companies need to aim for. Comprehensive clinical data, meanwhile, could support earlier review and approval of products – the Holy Grail for ambitious startups with new advanced therapies under development.
Capture every insight
Traditionally, Big Pharma has made information management the preserve of individual departments such as Quality, CMC or Safety, in support of a targeted use case: most notably marketing authorization holder (MAH) dossiers for regulatory submission.
Data flows in each silo inform individual summaries, overlaid with a product description – when, logically, the information flow should be the other way round. Even then, the picture isn’t complete: information should be feeding into this picture from the earliest research stages. Capturing every insight in a structured way would enable biotechs to track and report on every aspect of what they do, at any point now or in the future.
We advocate that companies take an architecture-based approach to the way they capture and manage information, rather than trying to find the optimum software application to meet all of their needs today. This involves embracing data standards, and ensuring that information can be exported and combined easily without risk of overlap or error.
Get involved with standards
One of the huge advantages biotechs have is that they can capitalize on the immense amount of work that has gone into setting new data standards and data exchange mechanisms. The latest data standards in pharma include CDISC and ISO IDMP.
There are also industry consortia working to encourage standards-based data exchange. One of the latest and most exciting examples, with direct relevance to biotechs, is Accumulus Synergy, which is developing a global information-exchange platform to transform how drug innovators and health regulators interact, using comparable parcels of data that have been compiled in a standardized way. Another is Pistoia Alliance, which aims to promote life sciences collaboration and accelerate innovation.
Biotech products are more complex than more-established pharma lines, which gives them a compelling reason to command a proactive role in these consortia and discussion forums about the future of data management and exchange.
Get the right help
Ultimately, in terms of ‘what good looks like’, the aim for biotechs should be to work towards a ‘living dossier’ – a live record of a product which tracks its evolution from conception. Keeping this vision in mind will help ambitious young startups avoid investing in unwieldy Regulatory bureaucracy so that they can focus more of their time and energy on their products.
If you’re a young biotech, reframing data management as an opportunity rather than a problem will help you to redefine what’s possible and get this right from the start. And there is plenty of biotech-specific help out there to ensure that your team sets out on the right foot.
About the authors:
Frits Stulp is Managing Director of Iperion, a Deloitte company, where he leads a team of regulatory/IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. In addition to having more than two decades’ industry and consultancy experience, Frits is regarded internationally as a subject matter expert on IDMP and he proactively shares his rich knowledge and experience wherever he can.
Duncan van Rijsbergen is a specialist in Regulatory Affairs Business Process Improvement, Structured Product Data, and Data Interoperability at Iperion, a Deloitte company.
Iperion, now part of Deloitte, is a globally operating life sciences consultancy firm that is paving the way to digital healthcare by supporting standardization and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.